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RT-PCR tests for SARS-CoV-2 processed at a large Italian Hospital and false-negative results among confirmed COVID-19 cases.在一家大型意大利医院进行的针对严重急性呼吸综合征冠状病毒2(SARS-CoV-2)的逆转录聚合酶链反应(RT-PCR)检测以及确诊的2019冠状病毒病(COVID-19)病例中的假阴性结果 。
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美国低流行地区一家三级医疗学术中心重复进行鼻咽部严重急性呼吸综合征冠状病毒2(SARS-CoV-2)逆转录聚合酶链反应(RT-PCR)检测的效用及诊断管理策略的优化

Utility of Repeat Nasopharyngeal SARS-CoV-2 RT-PCR Testing and Refinement of Diagnostic Stewardship Strategies at a Tertiary Care Academic Center in a Low-Prevalence Area of the United States.

作者信息

Lepak Alexander J, Chen Derrick J, Buys Ashley, Stevens Linda, Safdar Nasia

机构信息

Division of Infectious Diseases, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.

Department of Pathology and Laboratory Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.

出版信息

Open Forum Infect Dis. 2020 Aug 27;7(9):ofaa388. doi: 10.1093/ofid/ofaa388. eCollection 2020 Sep.

DOI:10.1093/ofid/ofaa388
PMID:32964068
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7494178/
Abstract

BACKGROUND

Multiple factors have led to an extremely high volume of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) reverse transcription polymerase chain reaction (RT-PCR) testing. Concerns exist about sensitivity and false-negative SARS-CoV-2 RT-PCR testing results. We describe a retrospective observational study examining the utility of repeat nasopharyngeal (NP) SARS-CoV-2 RT-PCR testing at an academic center in a low-prevalence setting.

METHODS

All patients within our health system with >1 NP SARS-CoV-2 RT-PCR test result were included. SARS-CoV-2 RT-PCR testing was performed according to 1 of 4 validated assays. Key clinical and demographic data were collected, including whether the patient was inpatient or outpatient at time of the test and whether the test was performed as part of a person under investigation (PUI) for possible coronavirus disease 2019 or for asymptomatic screening.

RESULTS

A total of 660 patients had >1 NP SARS-CoV-2 PCR test performed. The initial test was negative in 638. There were only 6 negative-to-positive conversions (0.9%). All 6 were outpatients undergoing a PUI workup 5-17 days after an initial negative result. In >260 inpatients with repeat testing, we found no instances of negative-to-positive conversion including those undergoing PUI or asymptomatic evaluation.

CONCLUSIONS

In a low-prevalence area, repeat inpatient testing after an initial negative result, using a highly analytically sensitive SARS-CoV-2 RT-PCR, failed to demonstrate negative-to-positive conversion. The clinical sensitivity of NP RT-PCR testing may be higher than previously believed. These results have helped shape diagnostic stewardship guidelines, in particular guidance to decrease repeated testing in the inpatient setting to optimize test utilization and preserve resources.

摘要

背景

多种因素导致严重急性呼吸综合征冠状病毒2(SARS-CoV-2)逆转录聚合酶链反应(RT-PCR)检测量极大。人们对SARS-CoV-2 RT-PCR检测结果的敏感性和假阴性存在担忧。我们描述了一项回顾性观察性研究,考察在低流行环境下的一个学术中心重复进行鼻咽(NP)SARS-CoV-2 RT-PCR检测的效用。

方法

纳入我们医疗系统内所有有超过1次NP SARS-CoV-2 RT-PCR检测结果的患者。SARS-CoV-2 RT-PCR检测按照4种经过验证的检测方法之一进行。收集关键的临床和人口统计学数据,包括检测时患者是住院患者还是门诊患者,以及该检测是否作为对疑似2019冠状病毒病的受调查者(PUI)或无症状筛查的一部分进行。

结果

共有660例患者接受了超过1次NP SARS-CoV-2 PCR检测。初始检测结果为阴性的有638例。只有6例从阴性转为阳性(0.9%)。所有6例均为门诊患者,在初始阴性结果后5 - 17天接受PUI检查。在超过260例接受重复检测的住院患者中,我们未发现从阴性转为阳性的情况,包括那些接受PUI或无症状评估的患者。

结论

在低流行地区,使用分析灵敏度高的SARS-CoV-2 RT-PCR对初始阴性结果的住院患者进行重复检测,未显示出从阴性转为阳性的情况。NP RT-PCR检测的临床灵敏度可能高于先前认为的水平。这些结果有助于制定诊断管理指南,特别是关于减少住院患者重复检测以优化检测利用和节约资源的指南。